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  • Title: Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.
    Author: Teichgräber U, Lehmann T, Ingwersen M, Aschenbach R, Zeller T, Brechtel K, Blessing E, Lichtenberg M, von Flotow P, Heilmeier B, Sixt S, Brucks S, Erbel C, Beschorner U, Werk M, Riambau V, Wienke A, Klumb C, Thieme M, Scheinert D.
    Journal: Cardiovasc Intervent Radiol; 2022 Dec; 45(12):1774-1783. PubMed ID: 36088609.
    Abstract:
    PURPOSE: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). MATERIALS AND METHODS: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. RESULTS: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). CONCLUSIONS: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).
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